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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94493

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 22, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Philips North America Llc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782116

Z-1829-2024
Recall number
Z-1829-2024
Initiated
April 22, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
32 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software R5.7.1 may not provide warning for low ventilation setting which may

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation

Code information

UDI-DI: (01)00884838099722(21) Serial Numbers: 41017 41024 41025 41041 41047 41051 41080 41089 41130 41143 41144 41189 41196 41226 41235 41286 41287 41344 41367 41413 41432 41433 41497 41520 70093 70099 70202 70260 70589 70996 81073 84370

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, KS, MS, NH and the countries of Austria, Croatia, Finland, France, Germany, Italy, Lebanon, Netherlands, Norway, Sweden, Switzerland, Thailand, United Kingdom.

device · product 2 of 2

Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782117

Z-1830-2024
Recall number
Z-1830-2024
Initiated
April 22, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
19 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software R5.7.1 may not provide warning for low ventilation setting which may

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation

Code information

UDI-DI: (01)00884838099739(21) Serial Numbers: 42029 42217 42246 71044 71774 85146 85645 85663 85664 85668 85677 85680 85681 85685 85700 85704 85705 85706 85713

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, KS, MS, NH and the countries of Austria, Croatia, Finland, France, Germany, Italy, Lebanon, Netherlands, Norway, Sweden, Switzerland, Thailand, United Kingdom.